Orr will join the firm’s D.C. office where he will counsel clients on FDA regulatory matters. He will work with Womble Bond Dickinson clients on regulatory and policy issues in the pharmaceutical and biotech sectors, such as exclusivity for drugs and biological products, life-cycle management, product classification, and biosimilars-related issues.

Since joining the FDA in 2013, Dan advised the agency’s Center for Drug Evaluation & Research (CDER). In that role, he developed wide-ranging, national policies for drugs and biological products and resolved regulatory issues in a portfolio of products with combined annual sales of more than $37 billion. Dan also advised CDER concerning the implementation of the Biologics Price Competition and Innovation Act (BPCI Act) and was the lead Regulatory Counsel for multiple biosimilar approvals as well as approvals of new drugs, biological products, and generic drugs. He assisted CDER concerning a number of novel regulatory issues such as reference product exclusivity, patent disputes under the BPCI Act, and life-cycle management for non-biologic complex products

“The competition for experienced FDA counsel is fierce right now, and in Dan, we have one of the best,” said Kurt Weaver, leader of Womble Bond Dickinson’s Food, Beverage & Agriculture Team. “He understands first-hand how the FDA views drug safety and other pharmaceutical and biotech regulatory issues, and that insight will prove invaluable to our clients.”

Chris Douglas, the leader of the firm’s Mass Torts Team, said, “The pharmaceutical and food industries are among the most highly regulated—and those regulations frequently result in conflict and litigation. Dan will help clients both avoid costly disputes and favorably resolve litigation when it does arise.”

“Helping clients navigate federal regulations is a key service of our D.C. office, and Daniel will be a great resource to food, drug and agriculture clients as they interact with the FDA,” said D.C. Office Managing Partner Pam Rothenberg.

Partner, US

We use cookies to enhance your experience of our website. By using our website you consent to the use of cookies. For more information about cookies, please use the "Cookies" link at the bottom of the page at any time or click here.

"Womble Bond Dickinson", the “law firm” or the "firm" refers to the network of member firms of Womble Bond Dickinson (International) Limited, consisting of Womble Bond Dickinson (UK) LLP and Womble Bond Dickinson (US) LLP. Each of Womble Bond Dickinson (UK) LLP and Womble Bond Dickinson (US) LLP is a separate legal entity operating as an independent law firm. Womble Bond Dickinson (International) Limited does not practise law. Please see www.womblebonddickinson.com/legal-notices for further details.

You are switching to the United States

This selection will switch the website from presenting information primarily about the United Kingdom to information about the United States. If you would like to switch back, you may use location selection options at the top of the page.

Please make the United States my default location.

Contact

Although we would like to hear from you, we cannot represent you until we know that doing so will not create a conflict of interest. Also, we cannot treat unsolicited information as confidential. Accordingly, please do not send us any information about any legal matter until we authorize you to do so. To initiate a possible representation, please call one of our lawyers or staff members.

By clicking the “ACCEPT” button, you agree that we may review any information you transmit to us. You recognize that, even if you submit information that you consider confidential in an effort to retain us, our review of that information will not create an obligation on us to keep it confidential and will not preclude us from representing another client directly adverse to you, even in a matter where that information could and will be used against you.

Please click the “ACCEPT” button if you understand and accept the foregoing statement and wish to proceed.